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A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months

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Trial Profile

A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Dec 2022

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At a glance

  • Drugs GSK 3389245A (Primary)
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions
  • Acronyms RSV PED-002
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 09 Dec 2022 Results published in the Journal of Infectious Diseases
    • 23 Dec 2020 Status changed from active, no longer recruiting to completed.
    • 22 Nov 2019 Planned End Date changed from 23 Nov 2020 to 18 Nov 2020.

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